Z-0278-2016Class II

HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery...

Name: Z-0278-2016 HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery...
Creator: Ethicon Endo-Surgery Inc
Published: 2015-09-23
License: https://open.fda.gov/license/

Ethicon Endo-Surgery Inc / initiated 2015-09-23 / Terminated / root cause: design

FDA source

Ethicon Endo-Surgery Inc began a recall of HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated for soft tissue incisions when bleeding... on 2015-09-23. FDA classified it as Class II and gives the reason as "Complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0278-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-23
Posted: 2015-11-16
Terminated: 2016-11-01
Recalling firm: Ethicon Endo-Surgery Inc
Product: HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.
Product code: LFL Instrument, Ultrasonic Surgical
Reason for recall: Complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging.
Root cause tag: design
FDA root cause: Device Design
Action: On October 5, 2015, the firm sent Urgent Medical Device Recall Removal Letters to their customers.
Quantity in commerce: 441,490 pieces
Distribution: Distributed US (nationwide) including the District of Columbia & Puerto Rico and in the countries of ARUBA, AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, ECUADOR, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, MEXICO, PANAMA, PERU, PHILIPPINES, SINGAPORE, SINGAPORE, THAILAND, TAIWAN & VIETNAM.
Product codes and lots: Model # HARH23: Batch # L90K2V, Exp Date 2019-02; Batch # L90K2W, Exp Date 2019-02; Batch # L90K2X, Exp Date 2019-02; Batch # L90V6P, Exp Date 2019-03; Batch #, L9109W, Exp Date, 2019-03; Batch #, L91739, Exp Date, 2019-04; Batch #, L91F3X, Exp Date, 2019-05; Batch #, L91H6F, Exp Date, 2019-05; Batch #, L91M6D, Exp Date, 2019-06; Batch #, L91W4Z, Exp Date, 2019-06; Batch #, L91Z2W, Exp Date, 2019-07; Batch #, L92002, Exp Date, 2019-07; Batch #, L9214D, Exp Date, 2019-07; Batch #, L92194, Exp Date, 2019-07; Batch #, L92673, Exp Date, 2019-08; Batch #, L92E3H, Exp Date, 2019-08; Batch #, L92G7W, Exp Date, 2019-09; Batch #, L92L5R, Exp Date, 2019-09; Batch #, L92L8T, Exp Date, 2019-09; Batch #, L92R3H, Exp Date, 2019-09; Batch #, L92U7M, Exp Date, 2019-10; Batch #, L92W9M, Exp Date, 2019-10; Batch #, L92Y2K, Exp Date, 2019-10; Batch #, L92Y5M, Exp Date, 2019-10; Batch #, L92Z3M, Exp Date, 2019-10; Batch #, L9361Y, Exp Date, 2019-11; Batch #, M9013T, Exp Date, 2019-12; Batch #, M90214, Exp Date, 2019-12; Batch #, M9029F, Exp Date, 2019-12; Batch #, M9041P, Exp Date, 2019-12; Batch #, M90550, Exp Date, 2019-12; Batch #, M90681, Exp Date, 2019-12; Batch #, M9094Y, Exp Date, 2019-12; Batch #, M90H4Y, Exp Date, 2020-01; Batch #, M90K10, Exp Date, 2020-01; Batch #, M90L6V, Exp Date, 2020-02; Batch #, M90N41, Exp Date, 2020-02; Batch #, M90U2V, Exp Date, 2020-02; Batch #, M90X1T, Exp Date, 2020-02; Batch #, M90Y5Y, Exp Date, 2020-02; Batch #, M9107H, Exp Date, 2020-03; Batch #, M9134X, Exp Date, 2020-03; Batch #, M9159T, Exp Date, 2020-03; Batch #, M91788, Exp Date, 2020-03; Batch #, M9180C, Exp Date, 2020-03; Batch #, M91D2P, Exp Date, 2020-04; Batch #, M91D7P, Exp Date, 2020-04; Batch #, M91E14, Exp Date, 2020-04; Batch #, M91J5X, Exp Date, 2020-04; Batch #, M91L28, Exp Date, 2020-05; Batch #, M91M8D, Exp Date, 2020-05; Batch #, M91P44, Exp Date, 2020-05; Batch #, M91P5A, Exp Date, 2020-05; Batch #, M91T75, Exp Date, 2020-05; Batch #, M91W2T, Exp Date, 2020-05; Batch #, M91W5C, Exp Date, 2020-05; Batch #, M91X4J, Exp Date, 2020-05; Batch #, M91X9A, Exp Date, 2020-06; Batch #, M91X9U, Exp Date, 2020-06; Batch #, M92303, Exp Date, 2020-06; Batch #, M9232T, Exp Date, 2020-06; Batch #, M9237E, Exp Date, 2020-06; Batch #, M9243M, Exp Date, 2020-06; Batch #, M9244V, Exp Date, 2020-06; Batch #, M92795, Exp Date, 2020-07; Batch #, M9283L, Exp Date, 2020-07; Batch #, M9294A, Exp Date, 2020-07; Batch #, M92961, Exp Date, 2020-07; Batch #, M92C66, Exp Date, 2020-07; Batch #, M92C90, Exp Date, 2020-07; Batch #, M92E9X, Exp Date, 2020-07; Batch #, M92G56, Exp Date, 2020-07; Batch #, M92G79, Exp Date, 2020-07; Batch #, M92J3C, Exp Date, 2020-08; Batch #, M92L92, Exp Date, 2020-08 & Batch #, M92N00, Exp Date, 2020-08. Model # HARH36: Batch #, L90K4P, Exp Date, 2019-02; Batch #, L90W33, Exp Date, 2019-03; Batch #, L90W7K, Exp Date, 2019-03; Batch #, L91023, Exp Date, 2019-03; Batch #, L9103T, Exp Date, 2019-03; Batch #, L91080, Exp Date, 2019-03; Batch #, L9110Z, Exp Date, 2019-03; Batch #, L91144, Exp Date, 2019-03; Batch #, L9124Z, Exp Date, 2019-04; Batch #, L9128A, Exp Date, 2019-04; Batch #, L9131N, Exp Date, 2019-04; Batch #, L9138J, Exp Date, 2019-04; Batch #, L9142T, Exp Date, 2019-04; Batch #, L91467, Exp Date, 2019-04; Batch #, L9150V, Exp Date, 2019-04; Batch #, L91562, Exp Date, 2019-04; Batch #, L91884, Exp Date, 2019-04; Batch #, L9191F, Exp Date, 2019-04; Batch #, L91D1W, Exp Date, 2019-05; Batch #, L91D3V, Exp Date, 2019-05; Batch #, L91E0Y, Exp Date, 2019-05; Batch #, L91E5M, Exp Date, 2019-05; Batch #, L91E8N, Exp Date, 2019-05; Batch #, L91H0G, Exp Date, 2019-05; Batch #, L91H9R, Exp Date, 2019-05; Batch #, L91J2N, Exp Date, 2019-05; Batch #, L91K6G, Exp Date, 2019-05; Batch #, L91L6M, Exp Date, 2019-05; Batch #, L91P2Z, Exp Date, 2019-06; Batch #, L91P5D, Exp Date, 2019-06; Batch #, L91P99, Exp Date, 2019-06; Batch #, L91T2H, Exp Date, 2019-06; Batch #, L91T7E, Exp Date, 2019-06; Batch #, L91T9U, Exp Date, 2019-06; Batch #, L91V2X, Exp Date, 2019-06; Batch #, L91V62, Exp Date, 2019-06; Batch #, L91W1T, Exp Date, 2019-06; Batch #, L91X5P, Exp Date, 2019-07; Batch #, L91Y0X, Exp Date, 2019-07; Batch #, L91Y8W, Exp Date, 2019-07; Batch #, L91Z0N, Exp Date, 2019-07; Batch #, L9204R, Exp Date, 2019-07; Batch #, L92092, Exp Date, 2019-07; Batch #, L9225Y, Exp Date, 2019-07; Batch #, L9232V, Exp Date, 2019-07; Batch #, L9238R, Exp Date, 2019-07; Batch #, L9244H, Exp Date, 2019-07; Batch #, L92524, Exp Date, 2019-07; Batch #, L9255U, Exp Date, 2019-08; Batch #, L9259G, Exp Date, 2019-08; Batch #, L9272N, Exp Date, 2019-08; Batch #, L9284X, Exp Date, 2019-08; Batch #, L9285V, Exp Date, 2019-08; Batch #, L9290A, Exp Date, 2019-08; Batch #, L92921, Exp Date, 2019-08; Batch #, L92952, Exp Date, 2019-08; Batch #, L92987, Exp Date, 2019-08; Batch #, L92A89, Exp Date, 2019-08; Batch #, L92C3L, Exp Date, 2019-08; Batch #, L92C57, Exp Date, 2019-08; Batch #, L92D3K, Exp Date, 2019-08; Batch #, L92D4D, Exp Date, 2019-08; Batch #, L92D9H, Exp Date, 2019-08; Batch #, L92E43, Exp Date, 2019-08; Batch #, L92E8A, Exp Date, 2019-08; Batch #, L92F0U, Exp Date, 2019-08; Batch #, L92F2W, Exp Date, 2019-08; Batch #, L92F5A, Exp Date, 2019-09; Batch #, L92G2F, Exp Date, 2019-09; Batch #, L92G4R, Exp Date, 2019-09; Batch #, L92G9M, Exp Date, 2019-09; Batch #, L92J1A, Exp Date, 2019-09; Batch #, L92J1K, Exp Date, 2019-09; Batch #, L92K1F, Exp Date, 2019-09; Batch #, L92K66, Exp Date, 2019-09; Batch #, L92K9X, Exp Date, 2019-09; Batch #, L92P2A, Exp Date, 2019-09; Batch #, L92P4K, Exp Date, 2019-09; Batch #, L92P5A, Exp Date, 2019-09; Batch #, L92R16, Exp Date, 2019-09; Batch #, L92R2M, Exp Date, 2019-09; Batch #, L92R79, Exp Date, 2019-09; Batch #, L92R95, Exp Date, 2019-09; Batch #, L92T2A, Exp Date, 2019-10; Batch #, L92T64, Exp Date, 2019-10; Batch #, L92T6X, Exp Date, 2019-10; Batch #, L92U09, Exp Date, 2019-10; Batch #, L92U51, Exp Date, 2019-10; Batch #, L92U5K, Exp Date, 2019-10; Batch #, L92V39, Exp Date, 2019-10; Batch #, L92V4E, Exp Date, 2019-10; Batch #, L92V89, Exp Date, 2019-10; Batch #, L92W83, Exp Date, 2019-10; Batch #, L92X1Z, Exp Date, 2019-10; Batch #, L92X5D, Exp Date, 2019-10; Batch #, L92X73, Exp Date, 2019-10; Batch #, L92Y5D, Exp Date, 2019-10; Batch #, L92Y9L, Exp Date, 2019-10; Batch #, L92Z0W, Exp Date, 2019-10; Batch #, L92Z1R, Exp Date, 2019-10; Batch #, L92Z7H, Exp Date, 2019-10; Batch #, L9302N, Exp Date, 2019-10; Batch #, L9307C, Exp Date, 2019-10; Batch #, L93086, Exp Date, 2019-10; Batch #, L9311H, Exp Date, 2019-10; Batch #, L93122, Exp Date, 2019-10; Batch #, L93196, Exp Date, 2019-11; Batch #, L93200, Exp Date, 2019-11; Batch #, L9325A, Exp Date, 2019-11; Batch #, L9327J, Exp Date, 2019-11; Batch #, L93280, Exp Date, 2019-11; Batch #, L9330R, Exp Date, 2019-11; Batch #, L9330W, Exp Date, 2019-11; Batch #, L9333C, Exp Date, 2019-11; Batch #, L9334R, Exp Date, 2019-11; Batch #, L9338D, Exp Date, 2019-11; Batch #, L9339Z, Exp Date, 2019-11; Batch #, L9343C, Exp Date, 2019-11; Batch #, L9347A, Exp Date, 2019-11; Batch #, L9348U, Exp Date, 2019-11; Batch #, L9352A, Exp Date, 2019-11; Batch #, L9353X, Exp Date, 2019-11; Batch #, L9353Y, Exp Date, 2019-11; Batch #, L9356M, Exp Date, 2019-11; Batch #, L9361E, Exp Date, 2019-11; Batch #, L9362R, Exp Date, 2019-11; Batch #, L9362Z, Exp Date, 2019-11; Batch #, L9364G, Exp Date, 2019-11; Batch #, M9002F, Exp Date, 2019-12; Batch #, M9004D, Exp Date, 2019-12; Batch #, M9004N, Exp Date, 2019-12; Batch #, M9016Y, Exp Date, 2019-12; Batch #, M9017T, Exp Date, 2019-12; Batch #, M90235, Exp Date, 2019-12; Batch #, M90275, Exp Date, 2019-12; Batch #, M9027Z, Exp Date, 2019-12; Batch #, M9030P, Exp Date, 2019-12; Batch #, M9038T, Exp Date, 2019-12; Batch #, M90444, Exp Date, 2019-12; Batch #, M9046H, Exp Date, 2019-12; Batch #, M90494, Exp Date, 2019-12; Batch #, M9051C, Exp Date, 2019-12; Batch #, M9057H, Exp Date, 2019-12; Batch #, M90601, Exp Date, 2019-12; Batch #, M9064E, Exp Date, 2019-12; Batch #, M9069Y, Exp Date, 2019-12; Batch #, M9071X, Exp Date, 2019-12; Batch #, M90764, Exp Date, 2019-12; Batch #, M9083G, Exp Date, 2019-12; Batch #, M90880, Exp Date, 2019-12; Batch #, M90902, Exp Date, 2019-12; Batch #, M9091P, Exp Date, 2019-12; Batch #, M9097G, Exp Date, 2019-12; Batch #, M90A5M, Exp Date, 2020-01; Batch #, M90A8A, Exp Date, 2020-01; Batch #, M90C39, Exp Date, 2020-01; Batch #, M90C87, Exp Date, 2020-01; Batch #, M90C88, Exp Date, 2020-01; Batch #, M90C89, Exp Date, 2020-01; Batch #, M90D1E, Exp Date, 2020-01; Batch #, M90D8J, Exp Date, 2020-01; Batch #, M90D9T, Exp Date, 2020-01; Batch #, M90E1U, Exp Date, 2020-01; Batch #, M90F06, Exp Date, 2020-01; Batch #, M90F1W, Exp Date, 2020-01; Batch #, M90F3K, Exp Date, 2020-01; Batch #, M90F5Y, Exp Date, 2020-01; Batch #, M90G00, Exp Date, 2020-01; Batch #, M90G2Y, Exp Date, 2020-01; Batch #, M90G78, Exp Date, 2020-01; Batch #, M90G7Y, Exp Date, 2020-01; Batch #, M90H28, Exp Date, 2020-01; Batch #, M90H7D, Exp Date, 2020-01; Batch #, M90H7E, Exp Date, 2020-01; Batch #, M90H84, Exp Date, 2020-01; Batch #, M90J09, Exp Date, 2020-01; Batch #, M90J6R, Exp Date, 2020-01; Batch #, M90J7R, Exp Date, 2020-01; Batch #, M90K0A, Exp Date, 2020-01; Batch #, M90K5F, Exp Date, 2020-01; Batch #, M90K7A, Exp Date, 2020-01; Batch #, M90K8X, Exp Date, 2020-01; Batch #, M90L1F, Exp Date, 2020-02; Batch #, M90L2K, Exp Date, 2020-02; Batch #, M90L3Z, Exp Date, 2020-02; Batch #, M90L6U, Exp Date, 2020-02; Batch #, M90M34, Exp Date, 2020-02; Batch #, M90M52, Exp Date, 2020-02; Batch #, M90N1M, Exp Date, 2020-02; Batch #, M90N4Z, Exp Date, 2020-02; Batch #, M90N7V, Exp Date, 2020-02 , Batch #, M90P2U, Exp Date, 2020-02; Batch #, M90P5J, Exp Date, 2020-02; Batch #, M90P7K, Exp Date, 2020-02; Batch #, M90R0A, Exp Date, 2020-02; Batch #, M90R2M, Exp Date, 2020-02; Batch #, M90R2N, Exp Date, 2020-02; Batch #, M90R4W, Exp Date, 2020-02; Batch #, M90R7W, Exp Date, 2020-02; Batch #, M90T1J, Exp Date, 2020-02; Batch #, M90T73, Exp Date, 2020-02; Batch #, M90T98, Exp Date, 2020-02; Batch #, M90U35, Exp Date, 2020-02; Batch #, M90U7F, Exp Date, 2020-02; Batch #, M90V0Y, Exp Date, 2020-02; Batch #, M90V32, Exp Date, 2020-02; Batch #, M90V5R, Exp Date, 2020-02; Batch #, M90V91, Exp Date, 2020-02; Batch #, M90W3V, Exp Date, 2020-02; Batch #, M90W6F, Exp Date, 2020-02; Batch #, M90W9J, Exp Date, 2020-02; Batch #, M90X29, Exp Date, 2020-02; Batch #, M90X4P, Exp Date, 2020-02; Batch #, M90X7D, Exp Date, 2020-02; Batch #, M90Y2N, Exp Date, 2020-02; Batch #, M90Y3U, Exp Date, 2020-02; Batch #, M90Y6R, Exp Date, 2020-02; Batch #, M90Y7Z, Exp Date, 2020-03; Batch #, M90Y9P, Exp Date, 2020-03; Batch #, M90Z7K, Exp Date, 2020-03; Batch #, M9100N, Exp Date, 2020-03; Batch #, M9101R, Exp Date, 2020-03; Batch #, M9103R, Exp Date, 2020-03; Batch #, M91110, Exp Date, 2020-03; Batch #, M9111J, Exp Date, 2020-03; Batch #, M9113E, Exp Date, 2020-03; Batch #, M9115C, Exp Date, 2020-03; Batch #, M9117X, Exp Date, 2020-03; Batch #, M91206, Exp Date, 2020-03; Batch #, M9122P, Exp Date, 2020-03; Batch #, M9124V, Exp Date, 2020-03; Batch #, M9127U, Exp Date, 2020-03; Batch #, M9129X, Exp Date, 2020-03; Batch #, M9132N, Exp Date, 2020-03; Batch #, M9134W, Exp Date, 2020-03; Batch #, M91398, Exp Date, 2020-03; Batch #, M9141W, Exp Date, 2020-03; Batch #, M9143P, Exp Date, 2020-03; Batch #, M9145E, Exp Date, 2020-03; Batch #, M9152A, Exp Date, 2020-03; Batch #, M9155F, Exp Date, 2020-03; Batch #, M9155G, Exp Date, 2020-03; Batch #, M9161E, Exp Date, 2020-03; Batch #, M9162M, Exp Date, 2020-03; Batch #, M9168V, Exp Date, 2020-03; Batch #, M91713, Exp Date, 2020-03; Batch #, M9172G, Exp Date, 2020-03; Batch #, M9176J, Exp Date, 2020-03; Batch #, M9180D, Exp Date, 2020-03; Batch #, M9180E, Exp Date, 2020-03; Batch #, M91848, Exp Date, 2020-04; Batch #, M91874, Exp Date, 2020-04; Batch #, M91897, Exp Date, 2020-04; Batch #, M91918, Exp Date, 2020-04; Batch #, M91950, Exp Date, 2020-04; Batch #, M91A06, Exp Date, 2020-04; Batch #, M91A3L, Exp Date, 2020-04; Batch #, M91C5U, Exp Date, 2020-04; Batch #, M91C8D, Exp Date, 2020-04; Batch #, M91D6Y, Exp Date, 2020-04; Batch #, M91D8F, Exp Date, 2020-04; Batch #, M91D8P, Exp Date, 2020-04; Batch #, M91E35, Exp Date, 2020-04; Batch #, M91E71, Exp Date, 2020-04; Batch #, M91E8E, Exp Date, 2020-04; Batch #, M91F2E, Exp Date, 2020-04; Batch #, M91F5D, Exp Date, 2020-04; Batch #, M91F88, Exp Date, 2020-04; Batch #, M91G2U, Exp Date, 2020-04; Batch #, M91G35, Exp Date, 2020-04; Batch #, M91G3Z, Exp Date, 2020-04; Batch #, M91G85, Exp Date, 2020-04; Batch #, M91H3F, Exp Date, 2020-04; Batch #, M91H6F, Exp Date, 2020-04; Batch #, M91H9G, Exp Date, 2020-04; Batch #, M91H9H, Exp Date, 2020-04; Batch #, M91J6A, Exp Date, 2020-04; Batch #, M91J7U, Exp Date, 2020-04; Batch #, M91J9U, Exp Date, 2020-04; Batch #, M91J9Y, Exp Date, 2020-04; Batch #, M91J9Z, Exp Date, 2020-04; Batch #, M91K5T, Exp Date, 2020-05; Batch #, M91L4L, Exp Date, 2020-05; Batch #, M91L4R, Exp Date, 2020-05; Batch #, M91L6V, Exp Date, 2020-05; Batch #, M91M03, Exp Date, 2020-05; Batch #, M91M06, Exp Date, 2020-05; Batch #, M91M1Y, Exp Date, 2020-05; Batch #, M91M29, Exp Date, 2020-05; Batch #, M91M35, Exp Date, 2020-05; Batch #, M91M5Z, Exp Date, 2020-05; Batch #, M91M7M, Exp Date, 2020-05; Batch #, M91N0N, Exp Date, 2020-05; Batch #, M91N15, Exp Date, 2020-05; Batch #, M91N2N, Exp Date, 2020-05; Batch #, M91N2P, Exp Date, 2020-05; Batch #, M91N2T, Exp Date, 2020-05; Batch #, M91N6Z, Exp Date, 2020-05; Batch #, M91N9G, Exp Date, 2020-05; Batch #, M91P2C, Exp Date, 2020-05; Batch #, M91P2D, Exp Date, 2020-05; Batch #, M91P8K, Exp Date, 2020-05; Batch #, M91P91, Exp Date, 2020-05; Batch #, M91R04, Exp Date, 2020-05; Batch #, M91R8A, Exp Date, 2020-05; Batch #, M91R8C, Exp Date, 2020-05; Batch #, M91R94, Exp Date, 2020-05; Batch #, M91T18, Exp Date, 2020-05; Batch #, M91T1N, Exp Date, 2020-05; Batch #, M91T2C, Exp Date, 2020-05; Batch #, M91T2M, Exp Date, 2020-05; Batch #, M91T41, Exp Date, 2020-05; Batch #, M91T7A, Exp Date, 2020-05; Batch #, M91T8F, Exp Date, 2020-05; Batch #, M91U2N, Exp Date, 2020-05; Batch #, M91U46, Exp Date, 2020-05; Batch #, M91U72, Exp Date, 2020-05; Batch #, M91U77, Exp Date, 2020-05; Batch #, M91U80, Exp Date, 2020-05; Batch #, M91U8C, Exp Date, 2020-05; Batch #, M91V2E, Exp Date, 2020-05; Batch #, M91V5J, Exp Date, 2020-05; Batch #, M91V72, Exp Date, 2020-05; Batch #, M91V7W, Exp Date, 2020-05; Batch #, M91V80, Exp Date, 2020-05; Batch #, M91W0E, Exp Date, 2020-05; Batch #, M91W38, Exp Date, 2020-05; Batch #, M91W5F, Exp Date, 2020-05; Batch #, M91W88, Exp Date, 2020-05; Batch #, M91W90, Exp Date, 2020-05; Batch #, M91X06, Exp Date, 2020-05; Batch #, M91X32, Exp Date, 2020-05; Batch #, M91X4F, Exp Date, 2020-05; Batch #, M91X4H, Exp Date, 2020-05; Batch #, M91X4K, Exp Date, 2020-05; Batch #, M91X6K, Exp Date, 2020-05; Batch #, M91X7Y, Exp Date, 2020-06; Batch #, M91Y2G, Exp Date, 2020-06; Batch #, M91Y3C, Exp Date, 2020-06; Batch #, M91Y71, Exp Date, 2020-06; Batch #, M91Y8T, Exp Date, 2020-06; Batch #, M91Z0X, Exp Date, 2020-06; Batch #, M91Z23, Exp Date, 2020-06; Batch #, M91Z39, Exp Date, 2020-06; Batch #, M91Z5E, Exp Date, 2020-06; Batch #, M91Z65, Exp Date, 2020-06; Batch #, M92015, Exp Date, 2020-06; Batch #, M9201W, Exp Date, 2020-06; Batch #, M9204A, Exp Date, 2020-06; Batch #, M9204C, Exp Date, 2020-06; Batch #, M9210M, Exp Date, 2020-06; Batch #, M92120, Exp Date, 2020-06; Batch #, M92141, Exp Date, 2020-06; Batch #, M9214Y, Exp Date, 2020-06; Batch #, M9215L, Exp Date, 2020-06; Batch #, M9217U, Exp Date, 2020-06; Batch #, M9219T, Exp Date, 2020-06; Batch #, M9221P, Exp Date, 2020-06; Batch #, M92233, Exp Date, 2020-06; Batch #, M9226X, Exp Date, 2020-06; Batch #, M9228L, Exp Date, 2020-06; Batch #, M9231D, Exp Date, 2020-06; Batch #, M9232M, Exp Date, 2020-06; Batch #, M92356, Exp Date, 2020-06; Batch #, M9237D, Exp Date, 2020-06; Batch #, M9239T, Exp Date, 2020-06; Batch #, M9240M, Exp Date, 2020-06; Batch #, M9241E, Exp Date, 2020-06; Batch #, M9243X, Exp Date, 2020-06; Batch #, M92443, Exp Date, 2020-06; Batch #, M9246N, Exp Date, 2020-06; Batch #, M9249D, Exp Date, 2020-06; Batch #, M92517, Exp Date, 2020-06; Batch #, M9251J, Exp Date, 2020-06; Batch #, M92554, Exp Date, 2020-06; Batch #, M9255P, Exp Date, 2020-06; Batch #, M9259G, Exp Date, 2020-06; Batch #, M9259T, Exp Date, 2020-06; Batch #, M92613, Exp Date, 2020-06; Batch #, M92634, Exp Date, 2020-06; Batch #, M9264E, Exp Date, 2020-06; Batch #, M9264N, Exp Date, 2020-06; Batch #, M92673, Exp Date, 2020-06; Batch #, M9269M, Exp Date, 2020-07; Batch #, M92718, Exp Date, 2020-07; Batch #, M92738, Exp Date, 2020-07; Batch #, M9275D, Exp Date, 2020-07; Batch #, M9275X, Exp Date, 2020-07; Batch #, M92783, Exp Date, 2020-07; Batch #, M9278N, Exp Date, 2020-07; Batch #, M9280J, Exp Date, 2020-07; Batch #, M92839, Exp Date, 2020-07; Batch #, M9284P, Exp Date, 2020-07; Batch #, M92880, Exp Date, 2020-02; Batch #, M92894, Exp Date, 2020-07; Batch #, M92928, Exp Date, 2020-07; Batch #, M92935, Exp Date, 2020-07; Batch #, M9295Y, Exp Date, 2020-07; Batch #, M9295Z, Exp Date, 2020-07; Batch #, M92A3A, Exp Date, 2020-07; Batch #, M92A59, Exp Date, 2020-07; Batch #, M92A84, Exp Date, 2020-07; Batch #, M92A8U, Exp Date, 2020-07; Batch #, M92C0A, Exp Date, 2020-07; Batch #, M92C2U, Exp Date, 2020-07; Batch #, M92C51, Exp Date, 2020-07; Batch #, M92C76, Exp Date, 2020-07; Batch #, M92C8Z, Exp Date, 2020-07; Batch #, M92C9H, Exp Date, 2020-07; Batch #, M92D1U, Exp Date, 2020-07; Batch #, M92D2G, Exp Date, 2020-07; Batch #, M92D6K, Exp Date, 2020-07; Batch #, M92D6N, Exp Date, 2020-07; Batch #, M92D6P, Exp Date, 2020-07; Batch #, M92D6R, Exp Date, 2020-07; Batch #, M92E1F, Exp Date, 2020-07; Batch #, M92E36, Exp Date, 2020-07; Batch #, M92E4N, Exp Date, 2020-07; Batch #, M92E5X, Exp Date, 2020-07; Batch #, M92E6U, Exp Date, 2020-07; Batch #, M92E7R, Exp Date, 2020-07; Batch #, M92E9V, Exp Date, 2020-07; Batch #, M92F1U, Exp Date, 2020-07; Batch #, M92F1V, Exp Date, 2020-07; Batch #, M92F38, Exp Date, 2020-07; Batch #, M92F3A, Exp Date, 2020-07; Batch #, M92F5J, Exp Date, 2020-07; Batch #, M92F7C, Exp Date, 2020-07; Batch #, M92G0M, Exp Date, 2020-07; Batch #, M92G1P, Exp Date, 2020-07; Batch #, M92G41, Exp Date, 2020-07; Batch #, M92G5F, Exp Date, 2020-07; Batch #, M92G7C, Exp Date, 2020-07; Batch #, M92H07, Exp Date, 2020-07; Batch #, M92H13, Exp Date, 2020-07; Batch #, M92H24, Exp Date, 2020-07; Batch #, M92H3H, Exp Date, 2020-07; Batch #, M92H4M, Exp Date, 2020-07; Batch #, M92H7D, Exp Date, 2020-07; Batch #, M92H9Z, Exp Date, 2020-07; Batch #, M92J2Y, Exp Date, 2020-07; Batch #, M92J9Z, Exp Date, 2020-08; Batch #, M92K27, Exp Date, 2020-08; Batch #, M92K36, Exp Date, 2020-08; Batch #, M92K53, Exp Date, 2020-08; Batch #, M92K71, Exp Date, 2020-08; Batch #, M92K7F, Exp Date, 2020-08; Batch #, M92L14, Exp Date, 2020-08; Batch #, M92L1L, Exp Date, 2020-08; Batch #, M92L1V, Exp Date, 2020-08; Batch #, M92M3V, Exp Date, 2020-08; Batch #, M92M76, Exp Date, 2020-08; Batch #, M92M9G, Exp Date, 2020-08; Batch #, M92N2A, Exp Date, 2020-08; Batch #, M92N4Y, Exp Date, 2020-08 & Batch #, M92N72, Exp Date, 2020-08. Model # HARH45: Batch #, L90K4R, Exp Date, 2019-02; Batch #, L90V8F, Exp Date, 2019-03; Batch #, L90X10, Exp Date, 2019-03; Batch #, L91358, Exp Date, 2019-04; Batch #, L91600, Exp Date, 2019-04; Batch #, L9166U, Exp Date, 2019-04; Batch #, L9168T, Exp Date, 2019-04; Batch #, L91809, Exp Date, 2019-04; Batch #, L91E83, Exp Date, 2019-05; Batch #, L91G7W, Exp Date, 2019-05; Batch #, L91J6R, Exp Date, 2019-05; Batch #, L91M0D, Exp Date, 2019-06; Batch #, L91M6C, Exp Date, 2019-06; Batch #, L91R4J, Exp Date, 2019-06; Batch #, L91U69, Exp Date, 2019-06; Batch #, L91W66, Exp Date, 2019-06; Batch #, L91Y4Y, Exp Date, 2019-07; Batch #, L91Z72, Exp Date, 2019-07; Batch #, L9207J, Exp Date, 2019-07; Batch #, L92360, Exp Date, 2019-07; Batch #, L9236W, Exp Date, 2019-07; Batch #, L9246M, Exp Date, 2019-07; Batch #, L9252P, Exp Date, 2019-07; Batch #, L9257K, Exp Date, 2019-08; Batch #, L92619, Exp Date, 2019-08; Batch #, L92690, Exp Date, 2019-08; Batch #, L9281C, Exp Date, 2019-08; Batch #, L9288P, Exp Date, 2019-08; Batch #, L9294J, Exp Date, 2019-08; Batch #, L92A2U, Exp Date, 2019-08; Batch #, L92A8A, Exp Date, 2019-08; Batch #, L92C8U, Exp Date, 2019-08; Batch #, L92D7A, Exp Date, 2019-08; Batch #, L92H1J, Exp Date, 2019-09; Batch #, L92H3T, Exp Date, 2019-09; Batch #, L92H79, Exp Date, 2019-09; Batch #, L92H7K, Exp Date, 2019-09; Batch #, L92J40, Exp Date, 2019-09; Batch #, L92K54, Exp Date, 2019-09; Batch #, L92K8Z, Exp Date, 2019-09; Batch #, L92L1C, Exp Date, 2019-09; Batch #, L92M3W, Exp Date, 2019-09; Batch #, L92P9N, Exp Date, 2019-09; Batch #, L92T19, Exp Date, 2019-10; Batch #, L92U1H, Exp Date, 2019-10; Batch #, L92V3L, Exp Date, 2019-10; Batch #, L92V8R, Exp Date, 2019-10; Batch #, L92W46, Exp Date, 2019-10; Batch #, L92X6G, Exp Date, 2019-10; Batch #, L92Y3C, Exp Date, 2019-10; Batch #, L92Y8Z, Exp Date, 2019-10; Batch #, L92Z8P, Exp Date, 2019-10; Batch #, L9303M, Exp Date, 2019-10; Batch #, L93240, Exp Date, 2019-11; Batch #, L93248, Exp Date, 2019-11; Batch #, L93426, Exp Date, 2019-11; Batch #, L9359C, Exp Date, 2019-11; Batch #, M9007E, Exp Date, 2019-12; Batch #, M9007F, Exp Date, 2019-12; Batch #, M90138, Exp Date, 2019-12; Batch #, M9024R, Exp Date, 2019-12; Batch #, M9025P, Exp Date, 2019-12; Batch #, M9030N, Exp Date, 2019-12; Batch #, M9047L, Exp Date, 2019-12; Batch #, M90545, Exp Date, 2019-12; Batch #, M9062G, Exp Date, 2019-12; Batch #, M9080T, Exp Date, 2019-12; Batch #, M90858, Exp Date, 2019-12; Batch #, M9097F, Exp Date, 2019-12; Batch #, M90C11, Exp Date, 2020-01; Batch #, M90C5Y, Exp Date, 2020-01; Batch #, M90D61, Exp Date, 2020-01; Batch #, M90E1V, Exp Date, 2020-01; Batch #, M90F7R, Exp Date, 2020-01; Batch #, M90G3W, Exp Date, 2020-01; Batch #, M90H03, Exp Date, 2020-01; Batch #, M90J4R, Exp Date, 2020-01; Batch #, M90M71, Exp Date, 2020-02; Batch #, M90M9E, Exp Date, 2020-02; Batch #, M90P0E, Exp Date, 2020-02; Batch #, M90T4D, Exp Date, 2020-02; Batch #, M90U8F, Exp Date, 2020-02; Batch #, M90W1V, Exp Date, 2020-02; Batch #, M90X96, Exp Date, 2020-02; Batch #, M90Z1G, Exp Date, 2020-03; Batch #, M90Z52, Exp Date, 2020-03; Batch #, M91053, Exp Date, 2020-03; Batch #, M9125X, Exp Date, 2020-03; Batch #, M9141X, Exp Date, 2020-03; Batch #, M9145F, Exp Date, 2020-03; Batch #, M9164C, Exp Date, 2020-03; Batch #, M9166Y, Exp Date, 2020-03; Batch #, M91984, Exp Date, 2020-04; Batch #, M91D17, Exp Date, 2020-04; Batch #, M91F19, Exp Date, 2020-04; Batch #, M91G1N, Exp Date, 2020-04; Batch #, M91H11, Exp Date, 2020-04; Batch #, M91J0M, Exp Date, 2020-04; Batch #, M91J2G, Exp Date, 2020-04; Batch #, M91L0A, Exp Date, 2020-05; Batch #, M91M1C, Exp Date, 2020-05; Batch #, M91P13, Exp Date, 2020-05; Batch #, M91R3J, Exp Date, 2020-05; Batch #, M91R4M, Exp Date, 2020-05; Batch #, M91R53, Exp Date, 2020-05; Batch #, M91U3L, Exp Date, 2020-05; Batch #, M91V21, Exp Date, 2020-05; Batch #, M91X28, Exp Date, 2020-05; Batch #, M91X4G, Exp Date, 2020-05; Batch #, M91X6W, Exp Date, 2020-06; Batch #, M91Y1Y, Exp Date, 2020-06; Batch #, M91Y3D, Exp Date, 2020-06; Batch #, M91Y7J, Exp Date, 2020-06; Batch #, M9202G, Exp Date, 2020-06; Batch #, M92126, Exp Date, 2020-06; Batch #, M92189, Exp Date, 2020-06; Batch #, M9222C, Exp Date, 2020-06; Batch #, M9224U, Exp Date, 2020-06; Batch #, M9246P, Exp Date, 2020-06; Batch #, M9255N, Exp Date, 2020-06; Batch #, M9273G, Exp Date, 2020-07; Batch #, M92884, Exp Date, 2020-07; Batch #, M9291P, Exp Date, 2020-07; Batch #, M92A24, Exp Date, 2020-07; Batch #, M92A67, Exp Date, 2020-07; Batch #, M92D6L, Exp Date, 2020-07; Batch #, M92E0X, Exp Date, 2020-07; Batch #, M92F1X, Exp Date, 2020-07; Batch #, M92F5K, Exp Date, 2020-07; Batch #, M92F8N, Exp Date, 2020-07; Batch #, M92J31, Exp Date, 2020-08; Batch #, M92J9N, Exp Date, 2020-08; Batch #, M92K6E, Exp Date, 2020-08; Batch #, M92L5C, Exp Date, 2020-08; Batch #, M92L5T, Exp Date, 2020-08; Batch #, M92L7G, Exp Date, 2020-08 & Batch #, M92N47, Exp Date, 2020-08.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0278-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0278-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-16

Product code LFL

K132612UnclassifiedHarmonic Ace+ Shears 23 Cm Length with Advanced Hemostasis, Harmonic Ace + Laparoscopic Shears 36 Cm Length with AdvanceEthicon Endo-Surgery, LLC / cleared 2013-10-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)